Placebo effect and placebo response are often used interchangeably – despite being two different phenomena. In this blog, we highlight the differences—and why it matters. Placebos are an important part of clinical research. But the impact of placebo use is a long-discussed matter in the biotech and pharmaceutical industry. While helpful in determining drug efficacy, certain factors make using placebos as drug comparators rather complicated. Most will say placebo treatment
Phase II and III trial failure due to unexpectedly large placebo response rates is still all too common. In this blog, we explain what this means and how clinical trials can better manage the placebo response.
Placebos are used in randomized, placebo-controlled controlled trials, in which one group (or more) receives the active treatment and the other group receives the placebo control. This type of study is considered the gold standard of clinical trials for three reasons.
Historically, interpretation of clinical trials relies on “assay sensitivity”, or the sensitivity to detect clinically meaningful differences between endpoints measured in the group of patients given active drug compared to the group of patients given placebo. Assay sensitivity can be influenced by many factors, including the study design, specific endpoints selected, number of clinical sites and, of course, the magnitude of the placebo response.
STAT News published “The Placebo Response: A Hidden Risk to COVID-19 Trials” written by Tools4Patient authors on October 13, 2020. The article, authored by Erica Smith PhD, VP of Business Development and Dominique Demolle PhD, CEO, was published in STAT’s First Opinion column. The article asserts that the success of the abundant drug development program for COVID-19 therapies
The search for drugs to treat and prevent SARS-CoV-2 infection is ongoing, with more than 1200 drugs in the pipeline and more 3,200 clinical trials planned or initiated as of 21 September 2020 (GlobalData). The success of these studies, however, may be at risk due to an invisible threat – the placebo response.